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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

House Overwhelmingly Passes User Fee Legislation

Posted 31 May 2012 | By

The House of Representatives voted overwhelmingly to support the Food and Drug Administration Reform Act (FDARA), sending the bill to a conference committee for an ultimate merger with the Senate's&nbsp;Food and Drug Administration Safety and Innovation Act (FDASIA).

House members voted 387 to 5 in support of the legislation, which would institute a package of reforms to the US Food and Drug Administration (FDA) and renew and create a series of industry-paid user fees to help fund FDA.

In a statement released shortly before the legislation's passage, House Energy and Commerce Committee Chair Fred Upton said FDARA "will ensure continuation of various FDA programs and the creation of new ones to facilitate the review and approval of life-saving and life-improving drugs and medical devices."

While the conference committee is unlikely to make drastic changes to the legislation, there are numerous differences to be ironed out between FDARA and FDASIA, including track-and-trace provisions present in the Senate bill but not present in the House bill. The committee is required under Congressional rules to limit any changes to matters considered by either chamber of Congress, although exceptions to the rule do exist for relatively minor changes.

Once the two bills are combined by the conference committee, the newly-amended bill be will voted on by both the House of Representatives and the Senate respectively before going before the President, who has indicated he will support the bill.